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Product Quality Research Institute evaluation of cascade impactor profiles of pharmaceutical aerosols. Part 3. Final report on a statistical procedure for determining equivalence.
Christopher D, Adams W, Amann A, Bertha C, Byron PR, Doub W, Dunbar C, Hauck W, Lyapustina S, Mitchell J, Morgan B, Nichols S, Pan Z, Singh GJ, Tougas T, Tsong Y, Wolff R, Wyka B. Christopher D, et al. Among authors: morgan b. AAPS PharmSciTech. 2007 Nov 2;8(4):E90. doi: 10.1208/pt0804090. AAPS PharmSciTech. 2007. PMID: 18181550 Free PMC article.
Performance of the Population Bioequivalence (PBE) Statistical Test Using an IPAC-RS Database of Delivered Dose from Metered Dose Inhalers.
Morgan B, Chen S, Christopher D, Långström G, Wiggenhorn C, Burmeister Getz E, Beresford H, Hoffelder T, Acerbi D, Andrews S, Berry M, Dey M, Joshi K, McKenry M, Pertile M, Strickland H, Wilcox D, Lyapustina S. Morgan B, et al. AAPS PharmSciTech. 2018 Apr;19(3):1410-1425. doi: 10.1208/s12249-017-0941-8. Epub 2018 Feb 12. AAPS PharmSciTech. 2018. PMID: 29435904
Cascade Impactor Equivalence Testing: Comparison of the Performance of the Modified Chi-Square Ratio Statistic (mCSRS) with the Original CSRS and EMA's Average Bioequivalence Approach.
Kurumaddali A, Christopher D, Sandell D, Strickland H, Morgan B, Bulitta J, Wiggenhorn C, Stein S, Lyapustina S, Hochhaus G. Kurumaddali A, et al. Among authors: morgan b. AAPS PharmSciTech. 2019 Jul 8;20(6):249. doi: 10.1208/s12249-019-1443-7. AAPS PharmSciTech. 2019. PMID: 31286316
Performance of Multiple-Batch Approaches to Pharmacokinetic Bioequivalence Testing for Orally Inhaled Drug Products with Batch-to-Batch Variability.
Burmeister Getz E, Carroll KJ, Christopher JD, Morgan B, Haughie S, Cavecchi A, Wiggenhorn C, Beresford H, Strickland H, Lyapustina S. Burmeister Getz E, et al. Among authors: morgan b. AAPS PharmSciTech. 2021 Aug 19;22(7):225. doi: 10.1208/s12249-021-02063-1. AAPS PharmSciTech. 2021. PMID: 34410557 Free PMC article.
2,044 results